Objective: Diabetic foot ulcer (DFU) is a severe complication of diabetes mellitus associated with poor prognosis, high mortality, and substantial economic burden. While biological factors are well studied, the psychosocial mechanisms affecting patients' quality of life (QoL) remain underexplored. Guided by Engel's biopsychosocial medical model, this study aimed to identify the psychosocial determinants of QoL in DFU patients and to examine the mediating pathways through which these factors exert their effects.
Methods: This cross-sectional study consecutively enrolled 126 DFU patients and their primary caregivers from a tertiary hospital between 2022 and 2024. Inclusion criteria included confirmed DFU diagnosis (IWGDF criteria), age ≥18 years, and presence of a caregiver. Patients with previous psychiatric disorders or incomplete medical records were excluded. Data were collected within 48 hours of admission using validated Chinese versions of nine instruments: Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS), Pittsburgh Sleep Quality Index (PSQI), Medical Coping Modes Questionnaire (MCMQ), Social Support Rating Scale (SSRS), Self-Perceived Burden Scale (SPBS), Caregiver Strain Index (CSI), Zarit Caregiver Burden Interview (ZBI), and Diabetes Specific Quality of Life Scale (DSQL). Demographic and clinical data were extracted from electronic medical records. Statistical analyses included univariate comparisons, stepwise multiple regression, and parallel multiple mediation models using bootstrap resampling (5,000 iterations) with SPSSAU.
Results: Among 126 patients (mean age 62.1±12.1 years; 62.7% male), the majority were rural residents (72.2%), had low education (72.2%), and low monthly income (<3000 yuan, 77.8%). Lower income was significantly associated with poorer DSQL scores (66.13±15.29 vs. 57.81±9.87, P=0.044). Severe pain (NRS 7–10) was linked to worse QoL (72.48±14.87, P=0.008). Stepwise regression analysis revealed that patient anxiety (β=0.407, P<0.001), maladaptive coping (β=0.302, P=0.001), poor sleep quality (β=0.239, P=0.009), lower monthly income (β=−0.276, P=0.002), and caregiver burden (β=0.197, P=0.018) independently predicted DSQL scores, explaining 54.3% of the variance (adjusted R²=0.543). All variance inflation factors were <3, indicating no multicollinearity. Bootstrap mediation analyses showed that patient depression operated fully through patient anxiety (indirect effect=0.246, 95% CI: 0.094–0.424) and poor sleep (indirect effect=0.149, 95% CI: 0.030–0.332). Similarly, pain severity fully mediated via patient anxiety and sleep quality. Caregiver anxiety fully mediated via patient anxiety and sleep quality, while caregiver depression fully mediated via patient sleep quality and caregiver burden.
Conclusion: Quality of life in DFU patients is determined by a complex interplay of psychological, behavioral, and social factors. Patient anxiety, sleep disturbance, maladaptive coping, pain severity, and caregiver burden serve as key mediating pathways. These findings support the biopsychosocial model and suggest that integrating psychological and sleep-focused interventions into routine DFU care may improve patient outcomes beyond conventional biomedical treatment.